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Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02709889
Recruitment Status : Terminated (Strategic considerations)
First Posted : March 16, 2016
Last Update Posted : September 19, 2019
Information provided by (Responsible Party):

Brief Summary:
To assess the safety and tolerability of rovalpituzumab tesirine in subjects with specific delta-like protein 3-expressing advanced solid tumors.

Condition or disease Intervention/treatment Phase
Malignant Melanoma Medullary Thyroid Cancer Glioblastoma Large Cell Neuroendocrine Carcinoma Neuroendocrine Prostate Cancer High Grade Gastroenteropancreatic Neuroendocrine Carcinoma Neuroendocrine Carcinoma Solid Tumors Drug: Rovalpituzumab tesirine Phase 1 Phase 2

Detailed Description:
This is a multicenter, open-label study involving multiple specific advanced solid tumor types, consisting of a dose escalation Part A followed by an expansion Part B. Cancer subtypes will be studied in separate disease-specific cohorts in both Parts. Eight separate cohorts will enroll malignant melanoma, medullary thyroid cancer (MTC), glioblastoma, large cell neuroendocrine carcinoma (LCNEC), neuroendocrine prostate cancer (NEPC), high-grade gastroenteropancreatic (GEP), neuroendocrine carcinoma (NEC), other NEC, and solid tumors other than the above.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study of Rovalpituzumab Tesirine in Subjects With Delta-Like Protein 3-Expressing Advanced Solid Tumors
Actual Study Start Date : August 2016
Actual Primary Completion Date : August 27, 2019
Actual Study Completion Date : August 27, 2019

Arm Intervention/treatment
Experimental: Rovalpituzumab tesirine
Rovalpituzumab tesirine 0.2-0.4 mg/kg will be administered intravenously on Day 1 of each 6-week cycle.
Drug: Rovalpituzumab tesirine
Other Name: SC16LD6.5

Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) [ Time Frame: 1 year ]
    The MTD will be determined for both dose level and dosing interval.

  2. Number of subjects with adverse events as a measure of safety and tolerability [ Time Frame: 1 year ]
    Adverse events and serious adverse events will be monitored throughout the dosing period and for approximately 1 year after.

Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 48 months. ]
    ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to RECIST v1.1 or PCWG3 criteria (for prostate cancer participants).

  2. Duration of response (DOR) [ Time Frame: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 48 months. ]
    DOR is defined as the number of days from the day the response criteria are met to the date that disease progression is objectively documented.

  3. Progression free survival (PFS) [ Time Frame: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 48 months. ]
    Duration from start of the treatment to disease progression or death (regardless of cause of death), whichever comes first.

  4. Maximum Plasma Concentration (Cmax) [ Time Frame: Cycles 1, 2 and 4: day 1 (pre-dose, 30 min post-dose, 6 hours post-dose), 3, 8, 15, 29; Cycles 3, 5 and above: day 1, 8, 15, 29; up to 1 year. ]
    Maximum plasma concentration is the highest concentration that a drug achieves in the blood after administration in a dosing interval.

  5. Overall survival (OS) [ Time Frame: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 48 months. ]
    OS is defined as number of days from the date of first dose of any study drug to the date of death

  6. Clinical benefit rate (CBR) [ Time Frame: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 48 months. ]
    CBR is defined as the percentage of participants with best overall response (confirmed or unconfirmed) of CR, PR or stable disease (SD).

  7. Area Under the Curve (AUC) [ Time Frame: Cycles 1, 2 and 4: day 1 (pre-dose, 30 min post-dose, 6 hours post-dose), 3, 8, 15, 29; Cycles 3, 5 and above: day 1, 8, 15, 29; up to 1 year. ]
    AUC of Rovalpituzumab tesirine.

  8. Anti-therapeutic Antibodies (ATA) [ Time Frame: Cycles 1, 2 and 4: day 1 (pre-dose, 30 min post-dose, 6 hours post-dose), 3, 8, 15, 29; Cycles 3, 5 and above: day 1, 8, 15, 29; up to 1 year. ]
    Incidence of ATAs against Rovalpituzumab tesirine.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed, unresectable advanced solid malignancy with documented disease progression after at least 1 prior systemic therapy
  • Disease is relapsed/refractory to prior standard systemic therapy or for which standard or curative therapy does not exist or is not considered appropriate by the Investigator.
  • Measurable disease as defined by RECIST 1.1
  • DLL3-expressing malignancy based on central immunohistochemical (IHC) testing of representative baseline tumor tissue (archived tissue or on-study biopsy). Positive is defined as staining in ≥ 1% of tumor cells.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Minimum life expectancy of at least 12 weeks
  • Subjects with a history of central nervous system (CNS) metastases must have documentation of stable or improved brain imaging for at least 2 weeks after completion of definitive treatment and within 2 weeks prior to first dose of Study Drug, off or on a stable dose of corticosteroids. Definitive treatment may include surgical resection, whole brain irradiation, and/or stereotactic radiation therapy. (Applicable to tumor types of non-CNS primary origin only)
  • Recovery to Grade 1 of any clinically significant toxicity (excluding alopecia) prior to initiation of study drug administration
  • Adequate hematologic and organ function as confirmed by laboratory values
  • Last dose of any prior therapy administered by the following time intervals before the first dose of study drug:

    1. Chemotherapy, small molecule inhibitors, radiation, and/or other investigational anticancer agents (excluding investigational monoclonal antibodies): 2 weeks.
    2. Immune-checkpoint inhibitors (e.g., anti-PD-1, anti-PD-L1, or anti-CTLA-4), monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or T-cell or other cell-based therapies: 4 weeks (2 weeks with documented disease progression).
  • Females of childbearing potential must have a negative beta human chorionic gonadotropin (β-hCG) pregnancy test result within 7 days prior to the first dose of study drug. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.

Exclusion Criteria:

  • Any significant medical condition, including any suggested by screening laboratory findings that, in the opinion of the investigator or sponsor, may place the subject at undue risk from the study, including but not necessarily limited to uncontrolled hypertension and/or diabetes, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease requiring hospitalization within 3 months) or neurological disorder (e.g., seizure disorder active within 3 months).
  • Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association (NYHA) Class III-IV within 6 months prior to their first dose of study drug.
  • Recent or ongoing serious infection, including:

    1. Any active grade 3 or higher (per NCI CTCAE version 4.03) viral, bacterial, or fungal infection within 2 weeks of the first dose of the study drug. Routine antimicrobial prophylaxis is permitted.
    2. Known seropositivity for or active infection by human immunodeficiency virus (HIV).
    3. Active Hepatitis B (by surface antigen expression or polymerase chain reaction) or C (by polymerase chain reaction) infection or on hepatitis-related antiviral therapy within 6 months of first dose of study drug.
  • Women who are pregnant or breastfeeding
  • Systemic therapy with corticosteroids at >20 mg/day prednisone or equivalent within 1 week prior to the first dose of study drug
  • History of another invasive malignancy that has not been in remission for at least 3 years. Exceptions to the 3year limit include non-melanoma skin cancer, curatively treated localized prostate cancer, ductal carcinoma in situ, and cervical cancer in situ on biopsy or squamous intraepithelial lesion on PAP smear.
  • Prior exposure to a pyrrolobenzodiazepine (PBD)-based drug, prior participation in a rovalpituzumab tesirine clinical trial, or known hypersensitivity to rovalpituzumab tesirine or excipient contained in the drug formulation, unless undergoing retreatment with rovalpituzumab tesirine in the context of this protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02709889

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Sponsors and Collaborators
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Study Director: AbbVie Inc. AbbVie
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: AbbVie Identifier: NCT02709889    
Other Study ID Numbers: SCRX001-006
First Posted: March 16, 2016    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Thyroid Neoplasms
Carcinoma, Neuroendocrine
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms, Neuroepithelial
Endocrine Gland Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases